The Effect of Transcatheter VSD Closure on Children's Appetite, Hormones and Growth

Completed

• Conditions: Ventricular Septal Defect; Growth Delay; Appetite Loss

• Registration Number: NCT05200910
• Lead Sponsor: Kayseri City Hospital

Brief Summary

In this study; Changes in appetite, hormones and growth of ventricular septal defect patients treated with non-surgical method were evaluated.

Detailed Description

The study included 20 patients whose ventricular septal defect closed percutaneously and 26 children as control group. The symptoms, anthropometric measurements and laboratory tests of patient group were recorded at initial, 1st month and 6th months after closure.

Anthropometric measurements; weight for age (WFA), height for age (HFA), body mass index (BMI) and their z scores, triceps skinfold thickness (TSF) and mid-upper arm circumference (MUAC) were recorded on admission. Patients with weight for height z score less than -2 were defined as malnutrition.

Questions about the symptoms like appetite, weight gain, frequency of illness, rate of breathing, fatigue were asked to all parents at initial. These questionnaires15 and visual analogue scale (for appetite) were repeated at 1st and 6th month visits.

During the initial evaluation, approximately 6 ml of venous blood samples were taken between 9:00-10:00 am after an average of 10 hours fasting. On the same day, IGFBP-3, Ghrelin and leptin,fasting blood glucose, insulin, IGF-1, IGFBP-3, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total protein, and albumin were measured.

Anthropometric measurements and laboratory tests were repeated at 1st and 6th month visits.

Study Timeline

• Study Start: 2018-07-16
• Primary Completion: 2019-06-01
• Study Completion: 2020-01-01
• Study First Submitted: 2021-12-03
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-07
• Last Update Submitted: 2022-01-07
• Study First Posted: 2022-01-21
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Pediatric patients who underwent transcatheter VSD closure

Exclusion Criteria

• Chromosomal abnormalities
• Additional systemic disease
• Systemic infections

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight Z score	6 months	The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD
Height Z score	6 month	The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD
Ghrelin	6 month	Change in serum ghrelin level of patients after interventional closure of VSD
Body mass index Z score	6 month	The change in the Z scores of the body mass index according to the age of the patients after the interventional closure of the VSD
Leptin	6 month	Change in serum leptin level of patients after interventional closure of VSD
Visual analogue scale	6 month	Change in Visual analogue scale of patients and parent after interventional closure of VSD. Values in this scale vary between 0-100 mm, values close to '0' are composed of words and images expressing a decrease in the patient's appetite, values close to '100' representing an increase in appetite.

Trial Locations

Locations (1)

Süleyman Sunkak; 🇹🇷 Kayseri, Kocasinan, Turkey